NCT04154475Unknown不适用
Dairy Intervention in People With Obesity
Medical University of Graz2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- fat mass
研究概览
简要总结
Obesity is associated with increased morbidity and mortality, but weight reduction is difficult to achieve. In this randomized controlled trial we will include 120 obese subjects. Subjects will be allocated to one of the 3 diet types (minus 500 kcal / d):
- Yoghurt diet: 500 g low-fat yogurt / d, about 1000-1100 mg calcium / d,
- Milk product diet: 500 g of low-fat milk or buttermilk / d, about 1000-1100 mg calcium / d
- Standard diet: 500 g soy yogurt / d, about 500 mg calcium / d Primary endpoint is the change in fat mass (baseline vs. 12 weeks), secondary endpoints are metabolic and endocrine parameters, gut microbiome, quality of life, hunger and satiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥30 kg/m²
- •Age of ≥18 and <60 years
- •Written informed consent before study entry
- •Willingness to introduce a dietary change to lose weight
排除标准
- •Serum calcium ≥2.7 mmol/l
- •Dislike or intolerance of dairy products, reporting adverse responses or allergy to dairy products
- •Pregnancy or lactating women
- •Having given birth in the last year or planning a pregnancy in the next 6 months
- •Menopause (as defined by FSH levels ≥30 IU/l)
- •Disorders associated with androgen excess and/or menstrual irregularities except PCOS (overt thyroid dysfunction, hyperprolactinemia, adrenal hyperplasia, androgen secreting tumors)
- •Malabsorption syndrome
- •Intake of medication influencing metabolic or endocrine parameters (insulin sensitizers, oral contraceptives, ...), obesity pharmacotherapeutic agents, or calcium supplements in the last 3 months before study entry
- •Regular intake of calcium supplements in the last 3 months before study entry
- •Lifestyle changes (changes in physical activity) or weight reduction (≥10% of body weight) in the last 3 months before study entry
结局指标
主要结局
fat mass
时间窗: 12 weeks
Changes in body fat mass assessed via dual-energy X-ray absorptiometry (DXA) (baseline vs. 12 weeks).
次要结局
- Total testosterone(12 weeks)
- waist circumference(12 weeks)
- HOMA-IR(12 weeks)
- HDL cholesterol(12 weeks)
- Free testosterone(12 weeks)
- BMI(12 weeks)
- hip circumference(12 weeks)
- Body composition-lean mass(12 weeks)
- Body composition-android fat mass(12 weeks)
- LDL cholesterol(12 weeks)
- HbA1c(12 weeks)
- stool microbiome(12 weeks)
- Systolic blood pressure(12 weeks)
- Body composition-gynoid fat mass(12 weeks)
- Satiety(12 weeks)
- AUCglucose(12 weeks)
- AUCinsulin(12 weeks)
- QUICKI(12 weeks)
- Triglycerides(12 weeks)
- androstenedione(12 weeks)
- DHEAS(12 weeks)
- Food craving(12 weeks)
- Body weight(12 weeks)
- Body composition-total body fat(12 weeks)
- HOMA-beta(12 weeks)
- MATSUDA(12 weeks)
- Quality of life during weight reduction(12 weeks)
- Compliance(12 weeks)
- Diastolic blood pressure(12 weeks)
- Total cholesterol(12 weeks)
- Free androgen index(12 weeks)
研究者
研究点 (2)
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